August 2016

FDA MedWatch: Eyesaline Eyewash by Honeywell - Recall

Monday, August 22, 2016

Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury. Although no injuries have been reported and no contamination was found in batch testing, there is a risk of product contamination with Klebsiella pneumoniae.

FDA MedWatch: Oxacillin for Injection, USP, 10g by Sagent - Recall

Friday, August 19, 2016

Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent initiated this recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate matter found within the solution after reconstitution. The particulate matter has been identified as iron oxide.

Although tuberculosis (TB) is no longer a leading cause of death in the United States, efforts to eliminate this potentially fatal disease are critical. After two decades of steady decline, the number of reported U.S. TB cases rose slightly in 2015 to 9,563, according to provisional data released by CDC.

AKF Press Release: Disaster Relief Program Activated to Help Kidney Patients Affected by Floods in LA and MS

Wednesday, August 17, 2016

The American Kidney Fund (AKF), the nation’s leading provider of charitable assistance to people with kidney failure, has activated its Disaster Relief Program to help dialysis patients affected by the devastating flooding in Louisiana and Mississippi.

PharmaTech, LLC of Davie, FL, is voluntarily recalling all liquid products from October 20, 2015 through July 15, 2016 as a precautionary measure due to a potential risk of product contamination with Burkholderia cepacia.

Teva Pharmaceuticals announced a voluntary recall of seven lots of Amikacin sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate matter. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected.

CDC Guidance for Travel and Testing of Pregnant Women for Zika

Tuesday, August 2, 2016

The Florida Department of Health (FL DOH) has identified an area with local mosquito-borne Zika virus transmission (active Zika virus transmission) in Miami. Based on the earliest time of symptom onset and a maximal two-week incubation period for Zika virus, this guidance applies to women of reproductive age and their partners who live in or traveled to this area after June 15, 2016.

2016 DOHMH Advisory #26: Tick-borne Disease Advisory

Monday, August 1, 2016

New York City (NYC) clinicians should be on the alert for patients with tick-borne diseases. This advisory presents key epidemiologic findings regarding reportable tick-borne diseases (TBD) in NYC and reminds clinicians of reporting requirements.

Sage Products is voluntarily initiating a nationwide recall of one lot of Comfort Shield Barrier Cream Cloths to the distributor and health care facility/user level. The recall is being initiated due to product contamination with the bacteria, Burkholderia cepacia. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening.